You have experience in Medical Affairs Governance & Compliance and you are looking for a new challenge?
Regional Operations Manager ICRO
Medical Affairs Governance & Compliance - Insights and Operations Lead:
1. Medical governance monitoring and business analyst including as needed
a. Conduct ad-hoc reporting requests for management or stakeholders
b. Conduct root cause or trend analysis
2. Support Oncology Global Medical Affairs and broader Oncology Medical Affairs (OMA) on the monitoring and follow-up of actions based on data from OMA View for Medical Affair activities
3. Define business requirements on new reporting requirements; works with implementation team on the implementation
4. Manages the ?health check? process including process design updates or training
5. Supports the training, testing and rollout of the reporting solutions
6. Coaches, develops and supports OMA team in use of monitoring tools
Minimum: Scientific qualification (PhD, MSc or Bachelor?s Degree) in an appropriate scientific discipline, quality-related field with an in-depth knowledge of the international pharmaceutical product development process, or degree from an accredited college or university.
Preferred - a minimum of 2 years? experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
Experience, Skills, Knowledge:
- Proven strong analytical, planning and executional skills ? Able to understand and work with enterprise and functional systems & data ? Strong skills to interpret business requirements (including metric definition ? Experienced in implementing and deploying projects/ changes in an organization ? A broad understanding of Quality Management, GCP / GVP and Risk Management processes ? A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
- Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.
- Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies
Do you think you are the right candidate? Therefore, we are looking forward to receive your CV!